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Last Updated: January 17, 2021

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VASOTEC Drug Profile

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When do Vasotec patents expire, and what generic alternatives are available?

Vasotec is a drug marketed by Biovail Labs Intl and Bausch and is included in two NDAs.

The generic ingredient in VASOTEC is enalapril maleate. There are twenty-seven drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the enalapril maleate profile page.

US ANDA Litigation and Generic Entry Outlook for Vasotec

A generic version of VASOTEC was approved as enalapril maleate by HERITAGE PHARMA on August 22nd, 2000.

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Drug patent expirations by year for VASOTEC
Drug Prices for VASOTEC

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Drug Sales Revenue Trends for VASOTEC

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Recent Clinical Trials for VASOTEC

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Brigham and Women's HospitalPhase 4
Novartis PharmaceuticalsPhase 4
University of Wisconsin, MadisonPhase 4

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Pharmacology for VASOTEC
Paragraph IV (Patent) Challenges for VASOTEC
Tradename Dosage Ingredient NDA Submissiondate
VASOTEC TABLET;ORAL enalapril maleate 018998

US Patents and Regulatory Information for VASOTEC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Biovail Labs Intl VASOTEC enalaprilat INJECTABLE;INJECTION 019309-001 Feb 9, 1988 DISCN Yes No   Start Trial   Start Trial   Start Trial
Bausch VASOTEC enalapril maleate TABLET;ORAL 018998-002 Dec 24, 1985 AB RX Yes No   Start Trial   Start Trial   Start Trial
Bausch VASOTEC enalapril maleate TABLET;ORAL 018998-005 Jul 26, 1988 AB RX Yes No   Start Trial   Start Trial   Start Trial
Bausch VASOTEC enalapril maleate TABLET;ORAL 018998-001 Dec 24, 1985 AB RX Yes No   Start Trial   Start Trial   Start Trial
Bausch VASOTEC enalapril maleate TABLET;ORAL 018998-003 Dec 24, 1985 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for VASOTEC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Biovail Labs Intl VASOTEC enalaprilat INJECTABLE;INJECTION 019309-001 Feb 9, 1988   Start Trial   Start Trial
Bausch VASOTEC enalapril maleate TABLET;ORAL 018998-002 Dec 24, 1985   Start Trial   Start Trial
Bausch VASOTEC enalapril maleate TABLET;ORAL 018998-005 Jul 26, 1988   Start Trial   Start Trial
Bausch VASOTEC enalapril maleate TABLET;ORAL 018998-003 Dec 24, 1985   Start Trial   Start Trial
Bausch VASOTEC enalapril maleate TABLET;ORAL 018998-001 Dec 24, 1985   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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